1+3 restrictions bill for generics & IMDs was passed
By Lee, Jeong-Hwan | translator Choi HeeYoung
21.04.28 16:13:13
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Up to three biological equivalence tests and clinical items may be directly shared
The first bill subcommittee of the Welfare Committee voted to revise the bill of Seo Young-seok and Seo Jung-sook
However, biological drugs such as high-tech new drugs and vaccines and medicines designated by the head of the MFDS may be exempted from regulations on "Common Biological Equivalence Testing and Clinical 1+3 Restriction."
On the 28th, the National Assembly's Health and Welfare Committee passed the 1+3 restrictions bill on drug co-development. The first bill subcommittee of the Welfare Committee voted to revise the bil
Lee, Jeong-Hwan(junghwanss@dailypharm.com)
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